The Department of Health and Human Services (HHS) has announced further delay for implementation of the updated Common Rule until January 2, 2019.
Updates to the Common Rule, which protects human subjects in biomedical research, were finalized in 2017 – marking the first time the Common Rule has been updated in nearly three decades. The updated changes aim to modernize protections for clinical trial participants. Some of the major provisions include:
- New and revised definitions for “human subject,” “identifiable biospecimen,” and “clinical trial,” among others
- New categories of secondary research that are exempt from the Common Rule
- Elimination of continuing review for minimal risk studies
- Revised informed consent requirements
Despite the additional six-month delay, institutions will be able to implement the main provisions of the rule before January 2, 2019.
ASCO has developed a summary of the key provisions and changes to help institutions and cancer researchers prepare for the changes. Stay tuned to ASCO in Action for future news and updates regarding the Common Rule.